ES2250263T3 - NASAL MASK. - Google Patents

Abstract

A improved nasal mask is disclosed for delivering CPAP therapy to patients. The nasal mask has a sliding engagement to the headgear. The sliding engagement allows substantial relative lateral movement eg: when face is distorted from sleeping on side, while still providing adequate compressive force to avoid side leakage. The sliding engagement also allows easy release from the headgear.

Description

Nasal mask

This invention relates to interfaces of patient particularly, but not only, to a nasal mask intended to be used to provide CPAP therapy to patients suffering from obstructive sleep apnea (OSA).

Background of the invention

In the technique of respiratory devices, there is a well known diversity of respiratory masks that cover a person's nose and / or mouth to provide a continuous filling around the nasal and / or oral areas of the face so that a gas with a pressure can be provided positive inside the mask to be consumed by the user or user. The use of such masks varies from high altitude breathing (for example, in applications aeronautical) to mining and fire applications, to various Medical diagnostic applications and therapeutic applications.

A requirement of such respiratory devices has been to provide an effective seal against the face of user to prevent the leakage of the gas supplied. Ordinarily, in technique mask configurations previous, a good shutter of the mask with the face had been achieved in many cases only with considerable discomfort for the user. This problem is crucial in most of the applications, especially in medical applications, which require the user to use that type of mask so I continue for hours or maybe even days. In such situations, the user will not tolerate the mask for long periods and Optimal diagnostic or therapeutic goals will not be achieved, or will be achieved with great difficulty and considerable discomfort of the user.

Where masks such as those used are used earlier in respiratory therapy, particularly in the obstructive sleep apnea (OSA) treatment using therapy of Continuous Positive Air Duct Pressure (CPAP), is generally provides in the art a vent for the expulsion of the derivative current or the expired gases to the atmosphere. That type of vent can be provided, by example, as part of the mask, or in the case of some respirators in which an additional duct is a carrier of expiratory gases, in the respirator. The expulsion of gas from the mask is essential to ensure that the carbon dioxide development during the interval of circulation. With typical flow rates in the treatment of CPAP, usually between 4 cm of H2O and 20 cm of H2O, prior art solutions with such vents have excessively noisy result causing irritation of the user and concentrated gas streams that irritated any bed couple.

Several solutions have been developed in the prior art to try to reduce noise when provides CPAP therapy. For example, in the Request for PCT Patent No. WO98 / 34665 it has been proposed that the vent includes an elastic cap with rounded edges in the opening to reduce noise. In PCT Patent Application No. WO00178382, provides a vent with a semiannular fin. However, These prior art methods are not completely satisfactory in eliminating the extraordinary noise created by A vent in the mask.

WO98 / 48878 describes a breathing mask that includes an air discharge opening cushioned that is connected to piped supply gases In a mask The discharge opening is damped by of an interchangeable tubular filter seated within a tubular duct that extends from the opening.

Summary of the invention

An object of the present invention is to try to provide a nasal mask that partially exceeds previously mentioned drawbacks of the prior art or which at least provides the industry with a useful option.

Consequently, the invention consists of a device for administering a gas supply to a user as defined in claim 1.

Preferred embodiments are defined in the claims 2 to 8.

Those skilled in the art to which the invention will suggest many changes in construction and realizations and applications that differ greatly from the invention without departing from the scope of the invention as defined in the appended claims. Disclosures and descriptions in this report they are purely illustrative and are not intended to Be limiting in any way.

The invention is based on the foregoing and contemplates also constructions of which are given the examples that follow.

Brief description of the drawings

A preferred form of the present invention is will be described below with reference to the drawings that are accompany, in which:

Figure 1 is a block diagram of a positive, continuous air duct pressure system, humidified (CPAP system) that can be used in combination with the present invention;

Figure 2 is an illustration of a mask nasal that can be used with the present invention;

Figure 3 is a front view of a mask nasal that illustrates a fixation of head equipment to the mask;

Figure 4 is a perspective view of a mask illustrating a plurality of application fasteners that they connect with the sliding strip;

Figure 5 is a perspective view of a mask showing a slip strip caught in the application fasteners;

Figure 6 is a side view showing the sliding strip;

Figure 7 is a perspective view of the mask illustrating exit vents according to the present invention;

Figure 8 is a perspective view of the mask illustrating the vent lid in place; Y

Figure 9 is a perspective view of the vent cover.

Detailed description of the preferred embodiments

The present invention provides improvements in the CPAP therapy field. In particular, an exit is described which is less noisy and has a more diffuse output current. Be you will appreciate that the nasal mask as described in the embodiment Preferred of the present invention can be used in the care respiratory in general or with a ventilator but it will be described now, later, with reference to the use in a system of humidified CPAP. It will also be appreciated that the vent of described output is equally applicable to all forms of Patent interface, in particular to an oral placement.

With reference to figure 1, it shows a Continuous Positive Air Duct Pressure (CPAP) system humidified in which a patient 1 receives pressurized gases and humidified through a nasal mask 2 (or other type of appropriate patient interface) connected to a type of conduit gas transport or inspiratory duct 3. It must be understood that the supply systems could also be VPAP (Pressure of Variable Positive Air Duct) and BiPAP (Duct Pressure Two Level Positive Air) or other numerous forms of therapy respiratory Inspiratory duct 3 is connected to the outlet 4 of a humidification chamber 5 containing a volume of water 6. The inspiratory duct 3 may contain means of heating or heating wires (not shown) that heat duct walls to reduce gas condensation wet inside the duct. The humidification chamber 5 is formed preferably from a plastic material and can have a very conductive base of heat (for example an aluminum base) that be in direct contact with a heater plate 7 of the humidifier 8. Humidifier 8 is provided with means of control, or electronic controller, 9 that can comprise a microprocessor-based controller that executes commands from Computer software stored in the associated memory.

Controller 9 receives inputs from such sources as user input means or the indicator 10 through the which a user of the device can, for example, establish a required value (preset value) of humidity or temperature of the gases supplied to the patient 1. The controller can also receive entries from other sources, for example, from temperature and / or sensors 11 and 12 speed of circulation at through connector 13 and plate temperature sensor 14 of heater. In response to the degree of humidity established by the user by means of indicator 10 of the input path of the value of the temperature and the other inputs, the controller 9 determines when (or at what level) activate heater plate 7 to heat the water 6 inside the humidification chamber 5. Custom that the volume of water 6 is heated inside the chamber 5 of humidification, water vapor begins to fill the volume of the chamber above the surface of the water and removed from the chamber 5 humidification through output 4 with the current of gases (eg air) provided from the means of gas supply or blower 15 entering the chamber through from entry 16. Gases exhaled from the patient's mouth go directly to the environment around you in the figure one.

The blower 15 is provided with means of variable pressure regulation, or a fan 21 of variable speed, which suck air or other gases through the blower entry 17. Fan speed 21 speed variable is controlled by electronic controller 18 (or alternatively the function of controller 18 could be performed by controller 9) in response to inputs from the controller 9 and at a set default required value of user (preset value) of the pressure or speed of fan by means of indicator 19.

Nasal Mask

Referring to figure 2, it shows in detail a nasal mask that can be used with the present invention The mask includes a hollow body 102 with a input 103 connected to inspiratory duct 3. Mask 2 is positioned around the nose of the user 1 with the equipment 108 of head secured around the back of the head of the patient 1. The restricted force of the head 108 on the hollow body 102 and the rest 108 of the forehead guarantees sufficient compression force on the mask pad 104, for provide effective sealing against the patient's face.

The hollow body 102 is constructed of a material relatively inflexible, for example, polycarbonate plastic. That type of material will provide the required stiffness as well as the transparency and is a relatively good insulator. The gases expiratory in the preferred embodiment of the present invention they are expelled through a valve in the mask 300, or alternatively through an additional expiratory duct (no shown), or by any other method as known in the technique.

Mask head equipment

Referring now to figures 2 and 3 the Head unit 108 is shown connected to the hollow body 102. The present invention instead of fixed or adjustable ties traditional uses a sliding application between the 108 head and hollow body equipment 102. This is achieved by a loop 120, which extends through fasteners 122, 124 of equipment on each side of head equipment 108 and on the part upper hollow body 102. Loop 120 is applied alternatively with surface mounted guides 126, 128 upper of the hollow body 102. The guides limit the loop 120 but allow you to slide in and out, which means that the 108 head team can move laterally, regardless of the hollow body 102.

The advantage of this solution is that as the face is contoured during various sleep positions, the team head is able to move with position changes while the mask remains in the correct position on the nose of the user and an effective shutter is maintained.

Additional guides 129, 130,131 allow the user adjusts the position of loop 120, which allows to obtain a different pressure on the seal that depends on the position of loop 120.

To better guarantee user comfort and effective pressure on the mask cushion 104, the equipment 108 head can be built using two strips that extend around the back of the user head as it shown in figure 2 or with a partial head cover or any other configuration, as is known in the art. In this in case the strips, or the partial cover of the head would be manufactured using neoprene but can also be manufactured using any other material, as is known in the art, that is comfortable for the Username.

In a further example, shown in Figures 4, 5 and 6, a nasal mask that uses a sliding strip is illustrated for fixing the head unit 108 to the hollow body 102. The strip 200, shown in figure 6 in isolation, it is constructed of polyacetal (Delrin 500P NC010) using injection molding techniques to Get a polished finish. This material, similar to other derivatives based on the nylon, with its polished finish it has a friction particularly low very effective, and slides with respect to the body gap 102 with very little resistance. As shown in Figure 4, the hollow body 102 includes a certain number of fasteners 202 of application, within which, in use, strip 200 of slip jumps elastically and applies with them, being substantial force necessary to remove the strip from the fasteners 202. This means that with normal use the strip 200 of sliding will remain retained within fasteners 202 of application. It will also be seen in Figure 4 that is provided a certain number of fasteners, to allow a pressure from different angles for different face shapes.

As shown in Figure 6, the strip of sliding includes a middle section 204 intended to move from alternative mode with respect to fasteners 202 that are applied, ending at each end with hooks 206, 208 that are fixed to the head team. The first hitch 206 is a complete loop to through which the head member 108 is permanently fixed, for example, with a velcro strip. The 208 loop at the other end, it is only a partial loop 210 designed so that a strip or loop of the head 108 team can easily be slipped inside or outside of open section 212 allowing easy removal and mask fixation.

It should be noted that the claims attached refer specifically to the patient interface and the outlet vent described below. The description previous referred to the mask and the mask head team is intended to describe a specific embodiment of an interface of patient that may be included in a patient interface with a outlet vent as described below.

Ventilation outlet

As shown in Figures 7 to 9, this invention includes an outlet vent 300 as part of the body portion The outlet vent 300 includes a certain number of openings 302, molded in body portion 102 or then drilled through the mold. The openings 302 are separated and partly surrounded by a certain number of partitions 304 that provide support for a filter cap that is installed on top of openings 302. The cover of filter is basically designed to avoid noise from another way would be generated by the circulation of gases through the openings 302 externally. The filter cover comprises a member 306 frame (shown in figure 9) that fits elastically on top of partition 304 and holds in place a half filter piece 308 that sits on top of partitions 304. Frame 306 includes large vents 307 such that the expiratory or biased current of the mask comes out of the openings 302 through the filter means 308 and outside the vent 307. The filter part 308 is preferably a medium (PM35) of Ecofit brand filter that has less tendency to block with moisture levels often found in such Applications.

The structure of the outlet vent allows that the filter medium be replaced when desired, that is necessary, in an easy and efficient way. The frame 306 can be easily disassembled, the filter medium 308 replaced and the Frame 306 placed by spring jump back into place. In addition, in the rare case where the filter medium is blocked, provide auxiliary vents 310 in frame 306 that marry separations 312 in partitions 304. Being the 310 auxiliary vents much smaller than the vents main 307 during normal use passes very little circulation to through them. If the filter medium 308 becomes blocked circulation is then forced through the vents auxiliary 310. This noise will be significantly greater than the normal and will indicate the need for maintenance to the user.

You have to keep in mind that providing that type of system, the present invention effectively minimizes noise generated by the expiratory gas outlet current of the mask. The present invention is of a low maintenance type and when replacement of the filter medium is required is a easy and simple operation. In addition to reducing the noise level, the circulation through the outlet vent is more diffuse. This avoid, for example, a gas circulation aimed at a couple sleeping or a similar current directed at the patient, either from them it would cause discomfort or wake the couple.

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The features described in the above description, in the claims and / or the accompanying drawings may, both separately and in any combination thereof, be material for carrying out the invention in various forms of

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Claims (8)

1. A device to manage a supply of gases to a user (1) comprising: a patient interface (2) that includes a body portion (102), in use in fluid communication with said supply of gases and supplying said gases to said user (1), said body portion (102) having a outlet vent (300), at least one opening (302) for allow the passage of gases into the atmosphere and a member (308) of detachable diffusion, characterized in that said outlet fan (300) includes a frame member (306) that can be mounted on said at least one opening (300), said diffusion member (308) is juxtaposed between said frame member (306) and said at least one opening (300) and wherein said frame member (306) and said body portion create a low resistance outlet (307) in parallel with a high resistance outlet (310), wherein said outlet (307) low resistance allows said gases to exit to said atmosphere through said diffusion member (308) and said high resistance outlet (310) allows gases to exit directly to said atmosphere. 2. A device to manage a supply of gases to a user (1) as claimed in the claim wherein said broadcast member (308) in use diffuses and audibly dampens a substantial portion of the gases expired from said user (1). 3. A device to manage a supply of gases to a user (1) according to claims 1 or 2, in which during normal use most of these expired gases passes through said vent (300) and exits through said Low resistance output (307), so if it is prevented substantially that most of these expired gases pass to through said low resistance output (307), most of said expired gases will exit through said discharge (310) high resistance. 4. A device to manage a supply of gases to a user (1) according to any one of the claims 1 to 3, wherein said high output (310) resistance comprises openings formed in said member (306) of frame or at the intersection between frame member (306) and said body portion (102). 5. A device to manage a supply of gases to a user (1) according to any one of the claims 1 to 4, wherein said high output (310) resistance is adapted so that in use, if said output (307) Low resistance is blocked or has a significant increase in the resistance, said high resistance output (310) ventilates a sufficient amount of gas to prevent breathing again the carbon dioxide expired by said user (1). 6. A device to manage a supply of gases to a user (1) according to any one of the claims 1 to 5, wherein said broadcast member (308) is a disposable medium (308) that reduces the level of audible noise exterior and that disseminates the circulation model that otherwise it would be produced from said gases that circulate through said vent (300). 7. A device to manage a supply of gases to a user (1) according to claim 6, wherein said disposable medium (308) is a filter material. 8. A device to manage a supply of gases to a user (1) according to any of the preceding claims, wherein said interface (2) of patient comprises a nasal mask (2) that has a portion (102) of hard body, an entrance (3) to said body portion (102) that receives said gas supply, sealing means (104) applied with said body portion (102), and intended to seal against the facial contour of said user (1), and help means (108) to said user (1) who provide a compressive force on said sealing means (104) to ensure that said gas supply is administered to a user (1) without leaks significant, said vent (300) comprising at least one opening (302) in said body portion (102).